MKJ · Class III · 21 CFR 870.5310

FDA Product Code MKJ: Automated External Defibrillators (non-wearable)

This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.

Leading manufacturers include Zoll Medical Corp, Zoll Medical Corporation, World Wide Headquarters and ZOLL Medical Corporation.

228
Total
228
Cleared
156d
Avg days
1985
Since
228 devices
145–168 of 228
Cleared May 15, 1997
700-SP SERIES DISPOSABLE STIMULATION ELECTRODES
K971148
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared Apr 16, 1997
700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES
K970719
Cardiotronics Systems, Inc.
Cardiovascular · 48d
Cleared Mar 06, 1997
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
K970391
Contour Medical Technology, Inc.
Cardiovascular · 31d
Cleared Jan 15, 1997
700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES
K964991
Cardiotronics Systems, Inc.
Cardiovascular · 33d
Cleared Nov 04, 1996
LIFEPAK 500
K955854
Physio-Control Corp.
Cardiovascular · 312d
Cleared Oct 24, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
K955882
Graphic Controls Corp.
Cardiovascular · 301d
Cleared Oct 24, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
K955923
Graphic Controls Corp.
Cardiovascular · 301d
Cleared Sep 10, 1996
FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS
K955628
Heartstream, Inc.
Cardiovascular · 274d
Cleared Jul 25, 1996
MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PHYSIO CONTROL DEFIBRILLATORS
K955828
Graphic Controls Corp.
Cardiovascular · 212d
Cleared Jul 02, 1996
DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
K960329
Contour Medical Technology, Inc.
Cardiovascular · 160d
Cleared May 07, 1996
CODEMASTER XL + XL W/SHOCK ADVISORY OPTION
K954957
Hewlett-Packard Co.
Cardiovascular · 193d
Cleared Jan 11, 1996
PEDIATRIC QUIK-COMBO
K953204
Physio-Control Corp.
Cardiovascular · 189d
Cleared Jan 04, 1996
HEARTSTART 911
K954609
Laerdal Medical Corp.
Cardiovascular · 92d
Cleared Nov 17, 1995
K-DEFIB/PACE PEDIATRIC ELECTRODE
K954504
Katecho, Inc.
Cardiovascular · 50d
Cleared Sep 07, 1995
MARQUETTE DEFIB ELECTRODES
K952101
Marquette Electronics, Inc.
Cardiovascular · 126d
Cleared Apr 20, 1995
MARQUETTE DEFIB ELECTRODE
K941262
Marquette Electronics, Inc.
Cardiovascular · 400d
Cleared Mar 13, 1995
ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR
K942344
Zoll Medical Corp
Cardiovascular · 301d
Cleared Feb 10, 1995
ZOLL POWERBASE(TM)
K942850
Zoll Medical Corp
Cardiovascular · 239d
Cleared Jan 24, 1995
K-DEFIB/PACE PEDIATRIC ELECTRODE
K934692
Katecho, Inc.
Cardiovascular · 481d
Cleared Dec 28, 1994
STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES
K943698
Zoll Medical Corp
Cardiovascular · 152d
Cleared Dec 22, 1994
360 SLX ADVISORY DEFIBRILLATOR
K935922
Medical Research Laboratories, Inc.
Cardiovascular · 374d
Cleared Dec 07, 1994
FAST-PATCH
K941970
Physio-Control Corp.
Cardiovascular · 229d
Cleared Jun 08, 1994
LIFEPAK 300 AUTOMATIC ADVISORY DEFRILLATOR
K925936
Physio-Control Corp.
Cardiovascular · 579d
Cleared Oct 08, 1993
PD-1400 PACER/DEFIBRILLATOR
K932028
Zoll Medical Corp
Cardiovascular · 165d